HAP Comment Letter to CMS about Stage 3 and Modifications to Meaningful Use in 2015 through 2016 Final Rule

December 14, 2015

Re: CMS-3310 &
3311-FC, Medicare and Medicaid Programs; Electronic Health Record Incentive
Program—Stage 3 and Modifications to Meaningful Use in 2015 through 2017 Final
Rule with Comment Period, October 15, 2015

Dear Mr. Slavitt:

On behalf of The
Hospital & Healthsystem Association of Pennsylvania (HAP), which represents
approximately 240 member institutions, including 125 stand-alone hospitals and
another 120 hospitals that comprise 32 health systems across the state, we
appreciate this opportunity to comment on the final rule for the Centers for
Medicare & Medicaid Services’ (CMS) Electronic Health Record (EHR)
Incentive Program—Stage 3 and Modifications to Meaningful Use during 2015
through 2017.

Hospitals strongly
support the use of EHRs and other technology to support our shared goals of
better coordinated, value-based care, and they have been working diligently to
implement new health information technology (IT) to improve the coordination,
quality and safety of care for patients. However, the complexity of the EHR
Incentive Program has required excessive spending and focus on meeting
meaningful use criteria; resources that could be better spent on patient care. HAP urges CMS to revise the EHR Incentive
Program framework to reflect program experience to date, provide flexibility in
the program measures so that providers can use certified EHRs to support
high-quality clinical care and patient engagement, and delay new program
requirements until the standards and infrastructure supporting the exchange of
health information are mature.

To reach the goal
of EHR adoption and use across a sizeable majority of eligible hospitals (EH),
critical access hospitals (CAH) and eligible professionals (EP), the EHR
Incentive Program framework and time frame must be reoriented to provide
operational and strategic flexibility for participating providers to enable
them to achieve our shared national vision of an e-enabled health care system.

This letter
provides HAP’s recommendations on how to improve the structure of the EHR
Incentive Program, increase flexibility to ensure program success, and base
meaningful use requirements on mature standards. Detailed comments on the Stage
3 objectives and measures are at the end of this letter.

REVISE THE PROGRAM FRAMEWORK
TO REFLECT EXPERIENCE TO DATE

The following
recommendations would create a structure for meaningful use that supports
program success.

Allow a reporting period of any 90
consecutive days in the first year of a new stage of meaningful use. HAP recommends
that a 90-day reporting period be available for the first year of Stage 3 and
any subsequent stages, and whenever there are changes to the definition of
certified EHR, including a new edition of technology or new functionality.
Experience to date indicates that the transition to new editions of certified
EHRs is challenging due to lack of vendor readiness, the necessity to update
other systems to support the new data requirements, the mandate to use immature
standards, an insufficient information exchange infrastructure and a timeline
that is too compressed to support successful change management. A 90-day
reporting period would give providers additional time to meet these challenges.

Postpone the required start of Stage 3 until
a date no sooner than 2019.
HAP recommends that CMS refrain from increasing EHR Incentive Program
complexity until the vast majority of eligible providers have attained the
current stage. Specifically, HAP
recommends that providers not be required to begin Stage 3 until at least 75
percent of EHs, 75 percent of CAHs and 75 percent of EPs have met Stage 2. A
requirement to start Stage 3 should not occur in advance of the start of the
new physician Merit-based Incentive Payment System (MIPS) and Advanced Payment
Model (APM), currently scheduled to begin during 2019. The voluntary start of
Stage 3 could be available during 2018.

EHR adoption rates
among hospitals have increased steadily since the program began in 2011;
however, according to data from CMS, fewer than 40 percent of hospitals
attested to Stage 2 meaningful use readiness during 2014. According to a recent
study, 67 percent of hospitals that had not yet met a proxy for Stage 2 during
2014 cited the ongoing costs of technology adoption as a challenge, while 57
percent cited the complexity of meeting meaningful use criteria.[1]

Additionally, the
disparity in EHR adoption rates persists, as evidenced by a gap of more than 10
percent between small and large hospitals in adoption of at least a basic EHR.[2]
More than half of hospitals reported challenges related to financial costs.[3]
The requirement to meet full- year regulatory requirements and ongoing
technology upgrades while the program moves from incentives to payment
penalties could create even greater challenges for resource-constrained
hospitals.

Moreover, failure
to successfully attest to meaningful use results in annual negative payment
adjustments. The reduction in Medicare reimbursement for those that do not meet
meaningful use objectives is 1.2 percent for 2016, and will be higher during
2017 and later years. All providers require sufficient time to implement and
upgrade technology and optimize performance before moving to more complex
requirements for use.

Eliminate the all-or-nothing approach in
meaningful use. The Health
Information Technology for Economic and Clinical Health (HITECH) Act, which was
part of the American Recovery and Reinvestment Act (ARRA) of 2009, defines a
meaningful EHR user as an EH, CAH and EP that demonstrates to the satisfaction
of the Secretary of Health and Human Services (HHS) during the reporting
period: the use of certified EHR technology in a meaningful manner; that
certified EHR technology is connected in a manner that provides for the
electronic exchange of health information to improve the quality of health
care, such as promoting care coordination; and that it submits information for
the reporting period, in a form and manner specified by the Secretary, on
clinical quality measures and such other measures as selected by the Secretary.
CMS states that the statute does not permit a change to the all-or-nothing
approach and requires more stringent measures of meaningful use to improve the
use of EHRs and health care quality over time. We disagree and believe that the
inclusion of more stringent measures does not prevent changes to the number of
objectives and measures required to meet the program requirements. HAP urges
CMS to adopt an alternate approach that advances widespread health IT adoption
by all EHs, CAHs, and EPs and sets requirements that are achievable and
practical. Specifically, HAP recommends
that EHs, CAHs, and EPs that attest to meeting 70 percent of the meaningful use
requirements be designated as having met meaningful use.

Provide an attestation period of sufficient
length to accommodate all EHs, CAHs, and EPs that will attest simultaneously. HAP is concerned that the 60-day
attestation time frame is too short to accommodate the simultaneous
attestations by as many as 665,000 EHs, CAHs, and EPs. In previous years, CMS’s
system has not been able to accommodate all those seeking to attest in an
efficient manner. Indeed, as a result, CMS has extended the attestation period
in the past due to these issues. Given past experience, we are concerned that
the site will be overwhelmed and providers will not be able to attest by the
deadline. Therefore, HAP recommends an
attestation period of 120 days following the end of the reporting period,
beginning during spring 2016.

Provider experience in the EHR Incentive
Program should inform future definitions of meaningful use. Stage 1 of meaningful use required program
participants to electronically capture health information. Stage 2 requires
program participants to electronically access and exchange health information
with patients and other clinicians. With 40 percent of EHs and about 10 percent
of EPs able to attest to Stage 2 during 2014, HAP recommends that CMS allow time for additional providers to attest
to Stage 2, commission an independent study of the experience with Stage 2, and
use the findings to inform Stage 3 requirements. Additionally, we recommend
that CMS study the experience and lessons learned from health reform
initiatives and new health care models that incentivize care coordination to
provide insight on advanced uses of health IT in support of better health
outcomes for patients, better health for populations and improved cost
containment.

PROVIDE FLEXIBILITY
IN PROGRAM REQUIREMENTS

The following
recommendations would give providers the flexibility they need to meet
meaningful use while pursuing our shared goals of better-coordinated,
value-based care.

Focus on the availability of mature
functionality in certified EHRs rather than thresholds that count the use of
functionality. In the
modifications rule 2015–2017, CMS revised the measure of patient engagement
with the certified EHR to focus on the availability of functionality to share
information with patients rather than counting how often the function was used.
Similarly, HAP recommends CMS modify
requirements in Stage 3 to emphasize the availability of EHR functionality,
rather than counting the number of times functionality is used. This
approach reduces measurement burden while ensuring capabilities are in place.
We recommend this approach for the following Stage 3 objectives: clinical
decision support (CDS), e-prescribing, patient electronic access to health
information, and coordination of care through patient engagement.

For example, HAP
recommends that CDS functionality in certified EHRs should be used by hospitals
to focus on priority health conditions that map to their own quality
improvement priorities, rather than specifically link use of CDS to a specified
number of clinical quality measures. Similarly, the requirement to count the
number of patients that receive electronic access to patient-specific education
materials forces providers to focus resources on counting patients. Rather,
providers should continue to utilize many tools—electronic and otherwise—to
provide patients with health information in the format that is most relevant
for each individual patient and easiest for the patient to access.

Provide a hardship exemption from meaningful
use penalties for any EH, CAH or EP that changes vendors during a reporting
period. In a September 2015
report on nonfederal efforts to help achieve health information
interoperability, the Government Accountability Office found that one of
several barriers to interoperability is the costs associated with achieving
interoperability, such as interfaces and EHR customization.[4]
HAP estimates that, between 2010 and 2013, hospitals collectively spent $47
billion each year on IT. The expense of adopting, implementing and upgrading
technology are ongoing, while the program demands certified EHRs support
information exchange for a full performance period. Given these conditions, a
decision to change vendors during a reporting period places providers in an
untenable position. Providers should not be penalized if their vendor is unable
to support them in meeting regulatory requirements. HAP recommends expanding the hardship exception categories to allow
providers to change EHR vendors during a reporting period to meet their needs
without the additional burden of a payment adjustment.

Ensure that any modifications to the program
requirements apply uniformly for all participants. The modifications rule includes several
changes to the EHR Incentive Program that aligned requirements for EHs, and
CAHs with those of EPs, including the shift to calendar year reporting, a
common attestation period, and the requirement to report the same objectives
and measures. HAP recommends that CMS
modifications to the definitions, structure, and reporting requirement of the
EHR Incentive Program for EHs and CAHs are aligned with requirements for EPs
pursuant to the creation of MIPS. This alignment is critical to ensuring
the ability to share information and improve care coordination among providers
across the continuum.

Provide flexibility in the measures to
support patient engagement with their providers. The availability of mature standards and
the opportunity to innovate will allow EHs and CAHs to identify ways to promote
patient engagement. Patient portal usage will increase as the sites become more
user-friendly and useful. The EHR Incentive Program requirements are not the
sole pathway to advance electronic patient engagement. The most recent data
from the 2015 Most Wired survey indicate that hospitals with more mature health
IT are going beyond meaningful use Stage 2 requirements to find ways to engage
their patients. For example, 63 percent of the Most Wired hospitals offer
self-management for chronic conditions through the patient portal, and 67
percent can incorporate patient-generated data through the portal. HAP recommends that CMS allow time for
optimization of existing EHRs to support insight on approaches to patient
engagement before requiring prescriptive patient engagement measures.

Additional
flexibility in measures also will require a reconsideration of the
applicability of measures intended to support patient engagement. In the Stage
3 final rule, CMS requires EHs and CAHs to use certified EHRs to send a secure
message to a patient or in response to a secure message sent by a patient, and
requires counting the secure messages in order to meet a specified threshold. HAP recommends that the secure messaging
measure to support coordination of care through patient engagement be
applicable to EPs only because patients typically engage with their physicians
to coordinate their care.

Postpone mandatory electronic reporting of
electronic clinical quality measures (eCQMs). HAP recommends that CMS allow time for EHs and CAHs to become
experienced with electronic submission of eCQMs before requiring electronic
submission of eCQMs for an entire reporting period in the EHR Incentive
Program. Experience to date indicates that very few EHs and CAHs are
electronically submitting eCQMs due to EHR inability to support accurate clinical
quality reporting. We recommend that CMS use the experience of eCQM reporting
in CMS quality programs to inform the requirements for eCQM reporting in Stage
3. Additionally, we recommend that CMS not impose requirements on providers
that the certified EHRs are not required to support. Currently, EHRs are not
required to support the reporting of all eCQMs. Providers must report on the
eCQMs that the technology has been certified to support.

ADOPT PROGRAM
REQUIREMENTS SUPPORTED BY MATURE INTEROPERABILITY STANDARDS AND INFRASTRUCTURE
ONLY

The following
recommendations would ensure that providers have the technical abilities and
infrastructure available to make the program successful.

Mature standards must exist before providers
are required by regulation to use them. The transition to new technology supporting Stage 2 has been a
challenge for providers due to lack of vendor readiness, mandates to use
untested standards, insufficient infrastructure to meet requirements to share
information and compressed timelines. HAP
recommends that CMS refrain from including requirements in regulations that
providers use a standard or functionality in certified EHRs in advance of
evidence that the standard or functionality is ready for nationwide use.

For example, it is
premature to require that providers use Application Programming Interfaces (API)
in the EHR to make health information accessible by any application (app) that
requests to access to the information. Although the Office of the National
Coordinator for Health Information Technology (ONC) finalized three
certification criteria in support of APIs in the 2015 Edition Certification
Rule, ONC specifically did not recognize a standard for APIs, citing standards
immaturity. Additionally, ONC finalized the API requirements without specifying
a certification approach or framework applicable to the apps that would extract
data from the EHR.

Requirements to use
new functionality such as APIs must be accompanied by standards that are
mature, rigorously tested and are accompanied by implementation guidance that
minimizes variation in the interpretation of the standard. Providers should not
be required to use APIs that have not been certified by ONC, nor should they be
required to share protected health information with apps that have not been
certified by ONC. Furthermore, given the sensitive nature of health
information, HHS should require all app developers to abide by HIPAA privacy
and security rules, whether or not they are covered entities. In a Privacy
Rights Clearinghouse study of mobile health and fitness applications, 43
percent of free applications were found to share user-generated personally
identifiable information with advertisers and 43 percent of the apps had a link
to the website’s privacy policy.[5]
CMS should work with ONC to include a requirement in the certification criteria
to address this gap in privacy and security protections.

Robust testing and implementation guidance
of mature standards must precede requirements for provider use. The experience using the consolidated
clinical data architecture (C-CDA) standard to exchange summary of care records
illustrates the problems with using standards that have not been adequately
specified. Hospitals that receive summary of care documents find they are too large
and it is difficult to find what is relevant and pertinent. For example, for
patients that require hospitalization: the patient record is managed by a
provider who will send a summary of care record to the hospital; the hospital
will send a summary of care record back to the provider upon discharge; and the
provider will receive a record with all laboratory results (current and
historic), imaging results and medications during the patient stay—a large
amount of information that is unlikely to indicate the most pertinent
information that will support ongoing management of the patient. This challenge
has been acknowledged by providers, vendors, and the government. The creator of
the C-CDA standard, HL7, is working to improve the C-CDA to make it more flexible
so that all information can be
exchanged and
relevant information can be presented in an accessible manner, but that work is
ongoing and has not been tested in real-world settings. Therefore, HAP recommends that CMS keep the threshold
for sharing summary of care documents at the modified Stage 2 level of 10
percent in Stage 3.

Focus on advancing interoperability. HAP recommends that CMS focus on
accelerating the exchange of data that is currently collected instead of
including requirements to collect new data. Prioritization of use cases that
accelerate the exchange of the current meaningful use data set that is being
captured to support care will build confidence and support for tackling the
capture and exchange of additional data elements. For example, the transition
to the unique device identifier (UDI) has just begun and will not be complete
until 2020. It will be a complex transition, as there are three separate
agencies that use different standards to create the UDI, which can be as long
as 75 characters. In addition to accommodating multiple UDI formats, EHRs also
will need to accept the data from different forms of automated ID technology
(such as a barcode or radio frequency identification tag). At the same time,
hospitals are learning how best to use the UDI and change operations to
accommodate it. HAP supports the deployment of the UDI because of the safety and
efficiency benefits it will bring. However, working through the standards
development and implementation issues to support effective use of the UDI is a
precursor to including the UDI as a data element in the common clinical data
set. Given the significant investments made to date, the current certified EHRs
must be a starting point for efforts to improve interoperability. The
development and growth of new models of care are incentivizing information
sharing by providers. HAP urges CMS to
allow the current market pressures for information exchange from consumers and
from new care delivery models to accelerate demand for information exchange.

While the demand
for information exchange grows, HAP
urges CMS to work with federal agencies to prioritize the development of a
patient identifier. Providers are experiencing challenges in identifying
patients and matching them to their medical records. The nation lacks a single
national mechanism for identifying individuals such as a unique patient
identifier. A single solution that would match individuals across IT systems
would allow providers to know with confidence that a patient being treated in
an emergency department is the same patient that a physician in another
location diagnosed with an acute or chronic health condition that requires
ongoing management. Patient safety concerns arise when data are incorrectly
matched, such as a patient’s current medication not being listed in the medical
record or the wrong medications are included in the record. Stage 3 includes a
measure requiring a clinical information reconciliation that includes
medications, medication allergy and current problem list for more than 80
percent of transitions or referrals in which the provider has never before
encountered the patient. This requirement would be easier to achieve with
advancement of a patient matching solution.

The ability to
optimize the functionality of certified EHRs is equally important to the
ability to use the EHRs in the delivery of safe and quality health care. During
the October 2015 joint meeting of the Health IT Policy and Health IT Standards
Committees, a committee member recounted the experience of nurses in a hospital
taking two hours to complete the documentation for the nursing admission
assessment. Two hours were required for the task due to the number of places in
the record where information was requested and the 537 clicks required to enter
the data. HAP recommends that CMS allow time for the evolution and maturation
of EHRs so that they support
providers with more nimble solutions supporting the time-sensitive and
high-reliability environment in which they are used.

DETAILED COMMENTS
ON THE STAGE 3 OBJECTIVES AND MEASURES

Protect Electronic Health
Information

HAP supports
retaining the measure as finalized for Stage 3.

e-Prescribing

Hospitals should
only be required to attest that they are using e-prescribing at discharge. HAP
opposes a threshold that is more than 10 percent. Hospitals are required to
report e-prescribing for the first time in Modified Stage 2 and require time to
address the technology upgrades, interfaces with other systems and workflow
modifications necessary to support this required measure.

Clinical Decision Support
(CDS)

HAP recommends
removing the tie between CDS and clinical quality measures in favor of
high-priority safety and quality improvement objectives of the hospital. This
would allow hospitals to determine how to use their EHR to meet quality
improvement goals and it would remove the measurement burden of tracking the
links between CDS and clinical quality measures.

HAP recommends the
continuation of the three measures with thresholds in the published Stage 3
final rule.

HAP recommends that
CMS not increase the thresholds above 60 percent.

HAP also recommends
that CMS clarify the provider that may claim attribution for the order.

Patient-Specific Education

Measure 1. HAP opposes the requirement to use API functionality for patient
engagement for educational resources or for health information exchange through
patient engagement in advance of a mature standard and certification of
patient-selected applications.

HAP opposes the
requirement to make patient health information available within 36 hours of its
availability to the provider for an eligible hospital or CAH through an API of
the patient’s choice as it would present operational challenges to hospitals.
We support continuation of making information available to view, download, or
transmit

Measure 2. HAP opposes the use of a specific threshold to monitor electronic
access to patient specific educational resources due to the absence of studies
that indicate an appropriate threshold for all providers. In the absence of
evidence, HAP recommends CMS focus on the functionality in the EHR and
commission a study that evaluates provider experience with use and optimization
of the functionality. We also recommend that CMS provide clarity about how the
EH, CAH, or EP would discern that the patient-specific educational resources
are actually generated by the certified EHR.

Patient Electronic Access
(View, Download, and Transmit)

Measure 1. HAP opposes the requirement to use API functionality for patient
engagement with a EH’s or CAH’s EHR in advance of a mature standard and
certification of patient-selected applications.

HAP opposes the use
of a specific threshold to monitor patient active engagement with the EHR and
recommends the continuation of the Modified Stage 2 approach for Measure 1 that
focuses on the availability of functionality in the EHR to support the
objective.

A study and
evaluation of provider experience with use and optimization of the
functionality will inform future requirements such as what or if thresholds are
necessary.

Measure 2. HAP recommends that the secure messaging measure be applicable only to
EPs as a patient is more likely to seek information from a primary care
provider following an acute care visit rather than contacting the hospital
directly. In addition, we believe it is appropriate to measure the provider’s
use of the secure messaging but not the patient’s responsiveness or utilization
of this technology. If EH/CAH use of secure messaging is included, CMS should
only require that functionality is enabled.

Measure 3. HAP believes it is premature to finalize a requirement that providers
use certified EHR functionality to support receipt of patient-generated data or
data from non-clinical settings from 15 percent of all unique patients. HAP
recommends that CMS study the experience of hospitals that are using the
patient-generated data to inform this regulatory proposal.

Summary of Care

Measure 1. HAP recommends retaining the modified Stage 2 threshold that EHs and
CAHs use their certified EHR to create and electronically send a summary of
care for more than 10 percent of transitions of for summary of care. There is
no evidence that the 50 percent threshold is attainable. HAP also recommends
that CMS allow access to a shared record to count for purposes of Measure 1.
The use of health information exchanges to make information available to
exchange participants also should count in the fulfillment of Measure 1.

Measure 2. HAP strongly recommends that the 40 percent performance threshold in
Measure 2 be modified to demonstrate the ability to consume a summary of care record
from at least one external EHR system.

Measure 3. HAP strongly opposes the 80 percent threshold for medical record
information reconciliation for new patients. This requirement precedes the
readiness of patient matching solutions and the availability of EHR interoperability that supports the exchange
and use of accurate health information within a recipient’s EHR without manual
effort.

Public Health

HAP recommends
retaining the modified Stage 2 requirement concerning the number of measures
reported for this objective. EHs and CAHs should report on three of four
measures.

HAP recommends the
retention of the modified Stage 2 specialized registry reporting option as one
category that includes both the public health registry and clinical data
registry. Case reporting can fit under the specialized registry reporting
option, as it is in Modified Stage 2. CMS should not include separate
categories for public health, clinical data, and case reporting registries.

HAP recommends a
requirement that registries that receive data from certified EHRs also must be
subject to certification.

HAP recommends the
continued availability of the alternate exclusions to the measures in the
public health reporting objective until the database of national, regional,
state registries is available to facilitate the measure reporting requirement.

HAP recommends that
CMS continue efforts to support public health agencies in their ability to
receive the data in accordance with the agreed upon standards.

Pennsylvania’s hospitals
are working toward a health care system where all providers are meaningfully
using certified EHRs to improve patient care and safety as well as achieve
national goals for improvement in the care of patients and populations. HAP
believes the recommendations presented in this letter will fulfill the goals of
the ARRA legislation to create a constructive and positive pathway for
nationwide adoption of EHRs. HAP believes the focus on increased EHR adoption
and on interoperability will ensure that EHRs and other health IT tools can
enable the efficient sharing of health information in support of care delivery,
patient engagement, and new models of care.

Thank you for your consideration
of our comments about this important final rule with comment. If you have any
questions, please feel free to contact me, or MartinCiccocioppo, vice
president, research, at (717) 561-5363.